Giving Donor Milk Instead of Formula in Moderate-Late Preterm Infants: the GIFT trial
Effect of supplementary pasteurised donor human milk compared with infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in moderate and late preterm babies – a randomised controlled trial
South Australian Health and Medical Research Institute
2,156 participants
May 27, 2024
Interventional
Conditions
Summary
The GIFT Trial is a randomised, controlled, blinded, parallel group trial to compare the effect of supplementary pasteurised donor human milk versus infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in clinically well pre-term infants born between 32+0 and 36+6, with a birth weight >=1500g and with insufficient maternal breast milk available. The GIFT Trial hypothesises that the use of donor milk instead of infant formula, as a supplement to maternal breast milk, in moderate-late preterm infants will reduce the time spent in hospital after birth.
Eligibility
Inclusion Criteria9
- +0 and 36+6 completed weeks’ gestation at birth;*
- Birth weight >= 1500g;
- Admitted to the neonatal unit;**
- Clinically stable as determined by the treating physician;
- Ready to commence enteral feeds or commenced enteral feeds with human milk but insufficient maternal breast milk is available as decided by the treating health care team;
- Aged <= 96 hours;
- Has a parent or guardian who is at least 16 years of age and is capable of giving informed consent.
- Only infants with a gestation of >=34 weeks at birth will be enrolled at the Royal Brisbane and Women’s Hospital, this is consistent with the process undertaken in our pilot study.
- If it is anticipated that an infant will be transferred to the postnatal ward or another hospital quickly (e.g. within 8 hours) then they will not be eligible for the study, as for practical reasons the study nutrition will not be able to be administered on the postnatal ward or to non-participating hospitals.
Exclusion Criteria3
- Documented, suspected or confirmed metabolic disorder that precludes breastfeeding;
- Major congenital malformation either likely to interfere with the ability to ingest milk or requiring surgery in the first 6 months of life ((including abnormalities of the central nervous system, cardiovascular system, urinary system, gastrointestinal system, chromosomal, metabolic, musculoskeletal, respiratory, diaphragmatic hernia, haematological, tumours or any other unspecified major abnormality);
- Has been given infant formula prior to randomisation.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Pasteurised donor human milk provided by Australian Red Cross Lifeblood. All milk will undergo microbiological screening before and after Holder pasteurisation (30 minutes at 62.5°C) according to Lifeblood policies. Mother’s own breast milk will always be given first and if supplementary feeds are required, then study nutrition will be used. Feeds will start at 10-15 ml/kg/day, and increasing 10-15 ml/kg/day or as per clinician discretion. Study nutrition will be provided from the day of randomisation for 15 days or earlier if there is sufficient mother’s own breast milk to support the target fluid intake, or the infant is discharged from hospital, to postnatal ward or transferred to another hospital. A research nurse will monitor fluid balance charts to monitor adherence to the study protocol during the intervention phase.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000289516